Med Shop Total Care, Inc.
FDA issued a warning letter to Med Shop Total Care, Inc. (Longview, TX), a compounding pharmacy, following a July 2021 inspection that identified serious insanitary conditions in sterile drug production. Violations included microbial contamination in the ISO 5 aseptic processing area, improper glove sanitization, inadequate disinfectant contact times, and a brownish residue on a HEPA filter screen — all causing drug products to be adulterated under FDCA section 501(a)(2)(A). The firm's corrective action responses were deemed inadequate in key areas, and FDA warned that failure to remediate could result in seizure or injunction.
Required actions (2)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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